Decisional Quality for Patients With Coronary Artery Disease (DeQCAD)

November 30, 2018 updated by: University of California, San Francisco

Decisional Quality for Patients With Stable Coronary Artery Disease

The objective of the DeQCAD study is to measure the quality of the decision-making process for patients with coronary artery disease (CAD) and Acute Coronary Syndrome (ACS) who are making treatment decisions. In particular, this study is seeking to answer: a) How informed are patients about their treatment choices, b) are patients participating in the decision-making process as much as they would like to, and c) do the treatment decisions made match patients' preferences?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For patients with coronary artery disease (CAD), having a stent (or percutaneous coronary intervention or PCI) involves both risk and inconvenience, and thus it represents a classic "preference-sensitive" situation, in which treatment decisions should be aligned with the patient's preferences.

In this project the investigators will develop the first comprehensive, patient-reported measure of decisional quality for CAD that is feasible to implement in a variety of settings. The investigators will accomplish this by: 1) Identifying the key elements to capture decisional quality and identifying candidate questions to address these elements, using patient and expert feedback; 2) Pilot testing a preliminary instrument in a diverse patient population to assess measurement properties and select a reduced set of candidate questions for further testing; and 3) Establish the reliability and validity of a new comprehensive decisional quality measure for single and repeated examinations. This will result in a multidimensional decisional quality instrument for patients with CAD that will be ready for implementation into routine care.

Study Type

Interventional

Enrollment (Actual)

677

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Mid-America Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients ≥ 18 years old
  2. Able to answer survey questions in English

  3. Diagnosis of coronary artery disease in one of the following categories:

    1. Stable CAD group

      • Meets any 1 of the following 3 criteria for stable CAD: 1) The patient has a clinical diagnosis or prior history of CAD; 2) Angina without change in frequency or pattern for the 6 weeks prior to enrollment; 3) Angina is controlled by rest and/or sublingual/oral/transcutaneous medications.
      • Accelerating pattern of stable angina with: 1) no ECG changes at rest; 2) no cardiac marker evidence of myocardial necrosis (e.g., elevated troponin or CK-MB); 3) scheduled for elective or urgent cardiac catheterization after being evaluated in the outpatient setting (i.e., not from the emergency department or inpatient hospitalization).
    2. Acute coronary syndrome group • Acute coronary syndrome where there is cardiac marker evidence of myocardial necrosis (e.g., elevated troponin or CK-MB) without new ST-segment elevation. Includes non-ST-elevation MI (NSTEMI).

Exclusion criteria:

  1. Diagnosis of ST-elevation MI (STEMI), defined as an acute coronary syndrome in which there is cardiac marker evidence of myocardial necrosis (eg, positive troponin or CK-MB) and new (or presumably new if no prior ECG is available) ST-segment elevation or left bundle branch block on the admission ECG.
  2. Unstable angina, defined as 1) Angina occurring at rest and prolonged, usually ≥ 10 minutes; 2) New onset angina of at least CCS classification III severity (i.e., marked limitation of ordinary physical activity - angina occurs on walking 1 to 2 blocks on the level and climbing 1 flight of stairs in normal conditions and at a normal pace); 3) no cardiac marker evidence of myocardial necrosis (e.g., negative troponin or CK-MB).
  3. Acute coronary syndrome with hemodynamic instability (e.g., cardiogenic shock, hypotension, cardiac arrest, ongoing or recurrent chest pain, dynamic ST change).
  4. Noncardiac chest pain: Pain in the chest, neck, arms, or abdomen (or other clinical manifestation) not clearly exertional or not otherwise consistent with pain or discomfort of myocardial ischemic origin.
  5. Cognitive impairment such that the patient cannot give informed consent for himself or herself.
  6. Unable to answer survey questions in English.
  7. Unavailable for follow-up surveys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Survey development
Patients with coronary artery disease will be given a survey to complete assessing their knowledge, communication with physicians, involvement, and treatment preferences after completing the treatment decision-making process.
Experimental: Decision Aid
Patients with stable coronary artery disease will be given a decision aid to review prior to making a treatment decision.
Behavioral: Decision Aid
Decision aid describing treatment choices for patients with coronary artery disease.
Active Comparator: CAD Education
Patient with coronary artery disease will be given a general educational handout on coronary artery disease.
Behavioral: CAD Education
Education for patients with coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision quality survey
Time Frame: 3 months post baseline
Decision quality for coronary artery disease patients making treatment decisions. Our primary outcome measure is the quality of the decision making process for patients with coronary artery disease including knowledge, communication, involvement, and treatment preferences measured at Baseline and 2 weeks during the pilot test phase, and Baseline, 1 month, and 3 months during the field test phase.
3 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Massachusetts General Hospital
Emory University
University of Missouri, Kansas City
Mid America Heart Institute

Investigators

  • Principal Investigator: R. Adams Dudley, MD, MBA, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL114918-01A1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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